P.F.C. SIGMA 1581-04-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295062608), received between Dec 18, 2017 and Sep 24, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

66 other recalls cover devices cleared under the same FDA submission (K033272, K040166, K082500, K241000, K943462, K961685); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT: PART: 158104008. LOT: 14071498. THE DEGVF IS THE RAW MATERIAL LOT. HOWEVER, IT COULDNT BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS PRODUCT COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE FROM (B)(6). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525502 ↗
• MalfunctionDec 16, 2020Difficult to Insert; Difficult to Insert

  THE INSERT, WHEN INSTALLED FROM THE LATERAL SIDE, DID NOT ADJOIN THE TIBIAL PLATFORM (THE LEFT KNEE JOINT ENDOPROSTHESIS WAS INSTALLED), ADDITIONAL PHYSICAL IMPACT DID NOT LEAD TO A RESULT. THERE WAS A NEED TO OPEN ONE MORE INSERT, THERE WERE NO PROBLEMS WHEN INSTALLING IT, THE LOCK CLICKED INTO PLACE. WHICH IS THE SOURCE OF THE ASSUMPTION THAT THERE MAY BE A PROBLEM WITH THE FIRST INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020148 ↗
• MalfunctionJun 27, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICES ARRIVED TO CUSTOMER DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739987 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DER STATES THAT PATIENT HAD SOME PAIN AND WAS UNABLE TO REACH FULL FLEXION. DOI: (B)(6) 2007; DOR; (B)(6) 2017; LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7164118 ↗
• InjuryDec 18, 2017Naturally Worn; Naturally Worn

  THE FOLLOWING IMPLANTS WERE REMOVED BY SURGEON DURING REVISION SURGERY DUE TO POLYETHYLENE WEAR AND TIBIAL AND FEMORAL LOOSENING SIZE 4 TIBIA. 866024, LOT 2063687; SIZE 4 LEFT CR FEMUR 960004, LOT UNREADABLE; SIZE 4 8MM PLI INSERT 158104008?, LOT 2048223 ORIGINAL SURGERY APPROXIMATELY 11 YEARS AGO. NO REPORT IS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7124975 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033272, K040166, K082500, K241000, K943462, K961685. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-0418-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definiti
• Z-0420-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0421-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0414-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0417-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0415-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or
• Z-0416-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or d
• Z-0423-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0413-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or def
• Z-0422-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0412-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0419-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• Z-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.

…and 51 more.